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Surgical Management of Optic Disc Pit Maculaopathy

NCT03185936 — Not applicable, Completed, 9 participants, Minia University

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Pars Plana Vitrectomy With Internal Limiting Membrane Peeling in Optic Disc Pit Maculopathy

RegistryNCT03185936
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment9 (Actual)
SponsorMinia University (Other)
ConditionsOptic Disc Structural Anomaly, Maculopathy
Interventionspars plana vitrectomy with internal limiting membrane (ILM) peeling (Procedure)
Datesstart 2011-03-01, primary completion 2016-04-01, completion 2017-04-01, first posted 2017-06-14, last updated 2017-06-14

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-Summary

To evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

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+Detailed description

As it is well known, optic disc pit (ODP) is a rare congenital disease which is usually associated with maculopathy (ODP-M) in the form of intraretinal and subretinal fluid accumulation at the macular area leading to visual impairment.

With no definite treatment and absence of guidelines for its management, the invistigators considered their prospective, interventional case series to evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

+Arms and interventions

ArmTypeInterventionsDescription
Optic disc pit maculopathyExperimentalProcedure: pars plana vitrectomy with internal limiting membrane (ILM) peelingpars plana vitrectomy with internal limiting membrane (ILM) peeling, endolaser
  • pars plana vitrectomy with internal limiting membrane (ILM) peeling (Procedure), also known as Endolaser photocoagulation: pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

+Outcome measures

Primary outcomes

  • anatomical improvement [6 months]: Retinal reattachment

Secondary outcomes

  • Functional improvement [6 months]: Visual acuity letters gain

+Eligibility

Sex: All, ages: 15 Years to 75 Years

Inclusion Criteria:

* Patients included in this study are those with ODP associated with macular detachment

Exclusion Criteria:

* Exclusion criteria included patients unfit for general anesthesia, those with insufficient clear media to perform the surgery with ILM peeling and those with other ocular diseases that can affect central macular thickness (CMT) and the best corrected visual acuity (BCVA).

+Investigators

  • Mahmud Genaidy, MD, Principal investigator, Assistant professor of ophthalmology, ophthalmology department, Minia university, Egypt

My Notes